Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062)

NCT01463683 | Completed Phase 3 Results

• 1 other identifier: V232-062
• Study Type: interventional
• Target: 722
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a study to evaluate immunogenicity, safety, and tolerability of 2XP HEPTAVAX™-II compared with the 1XP HEPTAVAX™-II in healthy Japanese young adults.

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Receiving Subcutaneous Vaccination Who Achieved Seroprotection

  Blood samples were collected for anti-hepatitis B antibody assays. Seroprotection was defined as ≥10 mIU/mL anti-hepatitis B antibody.

  Month 7

• Percentage of Participants With Injection-site Adverse Events

  Participants were evaluated for injection-site adverse events using MedDRA version 15.1

  Up to 15 days after each vaccination

• Percentage of Participants With Pyrexia Adverse Events

  Participants were evaluated for pyrexia adverse events using MedDRA version 15.1. Pyrexia (fever) was defined as an oral temperature ≥37.8°C ( ≥100.0°F).

  Up to 15 days after each vaccination

Study Arms (3)

V232-2XP SC

EXPERIMENTAL

2XP HEPTAVAX™-II vaccine 10 mcg in 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6

Biological: 2XP HEPTAVAX™-II SC

V232-1XP SC

ACTIVE COMPARATOR

1XP HEPTAVAX™-II vaccine 10 mcg in 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6

Biological: 1XP HEPTAVAX™-II SC

V232-2XP IM

EXPERIMENTAL

2XP HEPTAVAX™-II vaccine 10 mcg in 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6

Biological: 2XP HEPTAVAX™-II IM

Interventions

2XP HEPTAVAX™-II SC BIOLOGICAL

Also known as: RECOMBIVAX HB, HBVAXPRO

V232-2XP SC

1XP HEPTAVAX™-II SC BIOLOGICAL

Also known as: RECOMBIVAX HB, HBVAXPRO

V232-1XP SC

2XP HEPTAVAX™-II IM BIOLOGICAL

V232-2XP IM

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants provide written informed consent for the trial. The Participant may also provide consent for Future Biomedical Research. However, the Participant may participate in the main trial without participating in Future Biomedical Research.
• Participant is Japanese male or female, between 20 to 35 years of age on the day of the first study vaccination.
• Participant is determined to be in general good health based on the medical history taken on Day 1 prior to receiving the first injection of the vaccine. Any underlying chronic illness must be documented to be in stable condition.
• For females, a negative urine pregnancy test just prior to vaccination on Day 1.

You may not qualify if:

• Participant has a history of previous hepatitis B infection.
• Participant has a history of vaccination with any hepatitis B vaccine.
• \*Participant has a recent (≤72 hours) history of febrile illness (oral temperature ≥ 37.8°C).
• Participant has a known or suspected hypersensitivity to any component of HEPTAVAX™-II vaccine and latex (e.g., aluminum, yeast).
• Participant has a recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product, or is expected to require such blood-derived products during the study.
• \*Participant has received licensed inactivated vaccines within 14 days prior or licensed live vaccines within 28 days prior to first injection with the study vaccine.
• Participant has received investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine.
• Use of immunosuppressive therapy. Participants on corticosteroids should be excluded if they are receiving or are expected to receive, in the period from 4 weeks prior to enrollment until 6 weeks post vaccination, systemic doses greater than required for physiological replacement, i.e., \>5 mg of prednisone (or equivalent) per day for \>2 weeks (except for use of topical or inhalation steroid therapy).
• Pregnant women, nursing mothers, and women planning to become pregnant within the study period. Women of childbearing age should employ an acceptable method of contraception during the study (e.g., condom, diaphragm, oral contraceptive, Intrauterine Device (IUD), or hormonal implants are considered acceptable).
• Participant has any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
• Participant has a coagulation disorder contraindicating intramuscular injection.
• Participant has immunocompromised condition (such as Human Immunodeficiency Virus (HIV) positive, leukemia, lymphoma, other cancers or disorders).

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Kishino H, Takahashi K, Sawata M, Tanaka Y. Immunogenicity, safety, and tolerability of a recombinant hepatitis B vaccine manufactured by a modified process in healthy young Japanese adults. Hum Vaccin Immunother. 2018 Jul 3;14(7):1773-1778. doi: 10.1080/21645515.2018.1452578. Epub 2018 Apr 12.

  PMID: 29553862 RESULT

MeSH Terms

Conditions

Hepatitis B

Interventions

Recombivax HB; Hepatitis B Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: November 2, 2011
• Study Start: November 29, 2011
• Primary Completion: November 6, 2012
• Study Completion: November 6, 2012
• Last Updated: July 18, 2018
• Results First Posted: February 17, 2014

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share